What’s Up with Long-Term Follow-Up: Ethical, Regulatory, & Operational Challenges

Webinar

Presented on: December 5, 2024

Presented at: Virtual

This webinar was co-hosted by the MRCT Center and NYU’s Pediatric Gene Therapy and Medical Ethics (PGTME) Working Group as a part of their 5th Annual Lunchtime Learning Series. The panel on Long-Term Follow-Up (LTFU) was moderated by Dr. Carolyn Chapman and captured the ethical, regulatory, and operational challenges of LTFU studies through diverse viewpoints and perspectives.

What’s Up with Long-Term Follow-Up: Ethical, Regulatory, & Operational Challenges webinar recording


Health Literacy Month Webinar Series

Webinars

Presented on: October 10, 17, and 22, 2024

To celebrate Health Literacy Month, the MRCT Center presented three engaging and informative webinars to provide practical tools and discussions to incorporate health literacy and accessibility best practices into communicating participant-facing clinical research information. 

Designing PowerPoint Presentations to Support Health Literacy and Accessibility

Webinar

Presented on: October 22, 2024

Description: Spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham, the Research Ethics Action Collaborative for HRPPs (REACH) is an initiative designed to curate, align, and disseminate tools to advance representative inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community.

Join the REACH collaborative webinar on improving PowerPoint presentations through clear, accessible, and inclusive methods. We will show, through examples from the Accessibility by Design in Clinical Research Toolkit, how to apply accessibility tools to health literate communications. Because much communication is now virtual, we’ll explore how to make PowerPoint content readable and approachable, formatted for accessibility, and inclusive of people with disabilities.

Related Resources

Accessibility by Design (AbD) Toolkit

Creating and Sharing Plain Language Summaries: One Team’s Experience

Webinar

Presented on: October 17, 2024

Description: This webinar features experts from the Dana Farber Cancer Institute who will share their experience in developing a patient advocacy-driven return of results process for making Plain Language Summaries available to participants in breast cancer-related studies. 

The moderator, MRCT Center Program Director Sylvia Baedorf Kassis, is joined by panelists from the Dana-Farber Cancer Institute: Paula Steeves, Lead Patient Advocate, Breast Oncology, Christine McLaughlin, Patient Research Advocate, and Timothy Erick, Science Writer.

Key Topics:

  • The core elements of creating and disseminating Plain Language Summaries.
  • What results to return, who to involve in the creation process, and how to approach dissemination. 
  • How to start returning results with your study participants. Share your experiences and get answers to your questions in a moderated discussion and Q&A session.

Related Resources

Webinar Q&A

Speaker Biographies

https://www.dana-farber.org/cancer-care/treatment/breast-oncology/clinical-trials-research/plain-language-summaries

Designing Impactful Informed Consent Processes that Empower Participants

Webinar

Presented on: October 10, 2024

Description: This informative webinar leverages experience from the Office of Human Research Protections, the All of Us Research Program, and the MRCT Center to highlight resources and approaches for communicating informed consent information in innovative, participant-centered ways that support empowered decision-making.   

The moderator, Sylvia Baedorf Kassis, joins the panelists, Marianna Azar of the Office for Human Research Protections and Katherine Blizinsky from the All of Us Research Program. 

Key Topics:

Related Resources

Webinar Q&A

Speaker Biographies

https://mrctcenter.org/project/aggregate-results/

https://mrctcenter.org/health-literacy/

https://mrctcenter.org/health-literacy/instructional-resources/overview/irb/

https://mrctcenter.org/resources/covid-19-clinical-research-flyer/

https://mrctcenter.org/glossary/

https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-training/participant-centered-informed-consent-training/index.html

https://www.hhs.gov/ohrp/education-and-outreach/online-education/videos/index.html

https://www.hhs.gov/ohrp/education-and-outreach/luminaries-lecture-series/index.html

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/informed-consent/index.html

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html

https://www.allof-us.org/Roadmap   

www.allofus.nih.gov/about/who-we-are/all-us-participant-partners

www.allofus.nih.gov/about/protocol/all-us-consent-process

Session 2: Creating and Sharing Plain Language Summaries: One Team’s Experience  

Session 3: Designing PowerPoint Presentations to Support Health Literacy and Accessibility 

https://mrctcenter.org/mrct-center-annual-symposium/

Accessibility 101: How to Write Alt-Text and Map Participant Journeys

Webinar

Presented on: July 9, 2024

The MRCT Center and the Research Ethics Action Collaborative for HRPPs (REACH) presented the first webinar in the Accessibility 101 series on July 9, 2024

People with disabilities are the largest minority population in the United States, yet they are often excluded from clinical trials, both as participants and as researchers. Federal regulations, such as the recently updated Section 504 of the Rehabilitation Act, prohibit discrimination based on disability. Many accommodations are easy and low or no cost. It is incumbent upon all of us to build accessibility into our everyday thinking, meetings, presentations, and planning.

This webinar featured two interactive exercises in which participants learned:

  • Basic information about disability statistics and disability rights, and, as shown through the Accessibility by Design in Clinical Research Toolkit, different types of support that you can readily implement.
  • How to find the Check Accessibility and Alt Text features in PowerPoint and write appropriate Alt Text.
  • How to map out the participant’s (and family caregiver’s or supporter’s) journey from different disability perspectives, from getting to/into the site location, navigating within the site to the different areas they must access, and interacting with different forms of medical equipment and technology.

More about REACH: Research Ethics Action Collaborative for HRPPs (REACH) is an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham to curate, align, and disseminate tools to advance access to and inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community. Click here to learn more.

Related Resources

Accessibility Resources by webinar slide
Accessibility 101: Questions and Answers
Accessibility by Design (AbD) Toolkit


Data Collection and Privacy: Tools and Resources for LGBTQIA+ Inclusion by Design

Webinar

Presented on: June 11, 2024

The MRCT Center added two new tools to the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit: the SOGI Data Collection Checklist and the SOGI Data Privacy Checklist.

During this webinar we discussed:

  • The critical role of representation in clinical research, particularly for LGBTQIA+ communities, and an overview of the foundations supporting the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit.
  • Essential considerations for collecting SOGI data, covering survey and form design, appropriate language in study materials, and the protocols for collecting, storing, and sharing SOGI data.
  • Practical implementation examples and areas that require further research and guidance.

Related Resources

MRCT Center Resources

Other Resources – by slide:

(slide 19)

(slide 24)

(slide 40)

(slide 44)

(slide 45)

Action and Influence: Implementing the Clinical Research Glossary and Your Critical Role in Public Review

Webinar

Presented on: June 4, 2024

Learn how four organizations, Mass General Brigham (MGB) Rally, HonorHealth, the Society for Clinical Data Management (SCDM), and the CureMito Foundation, are implementing the MRCT Center’s Clinical Research Glossary and how you can participate in Public Review, a vital process to ensure the glossary is a CDISC global standard.

Related Resources

Webinar Biobook
The Clinical Research Glossary: Learn More
The Clinical Research Glossary: Working Group
Implementing the Clinical Research Glossary: How to Attribute the MRCT Center
On-Demand Webinar: The Clinical Research Glossary: New Words, New Opportunities
On-Demand Webinar: A Global Standard for Plain Language in Clinical Research: an MRCT Center and CDISC Collaboration

The Clinical Research Glossary: New Words, New Opportunities

Webinar

Presented on: April 2, 2024

With over 160 definitions, including images and supportive information, the Clinical Research Glossary has been designed to support the communication of clear research information, along with tailored, shareable images to foster engagement and understanding.

Learn more about:

  • Building trust and transparency with participants through plain language information sharing.
  • The dedicated team members, and robust process that is followed, to create this global standard.
  • Strategies and approaches to implement the Clinical Research Glossary content into patient-facing materials. 

Related Resources


REACH: Advancing DEI in Human Participant Research

Webinar

Presented on: March 7, 2024

Introducing Research Ethics Action Collaborative for HRPPs (REACH), an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham to curate, align, and disseminate tools to advance access to and inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community. 

We Need Your Voice:
Your perspective is invaluable to us. Help guide our efforts to improve research access and inclusion by sharing your thoughts via our brief survey. Your feedback is critical in shaping the tools and resources we develop and disseminate.

Related Resources

Panelist Biographies
List of resources shared during the webinar
Questions & Answers
Survey